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NCT04245501 · ClinicalTrials.gov registry record · NA
Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety
A NA study of Anxiety Disorders, sponsored by University of Denver.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04245501: Completed NA study of Anxiety Disorders, sponsored by University of Denver.
NCT04245501 is a NA study of Anxiety Disorders that has completed, run by University of Denver. The registered enrollment target is 50 participants, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04245501, a NA study of Anxiety Disorders, has completed, sponsored by University of Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Anxiety is the most common mental health problem in children and adolescents. This two-phased study will test the effects of an experimental computerized intervention aimed at reducing threat-based thinking (i.e., interpretation bias) in anxious youth. Participants in both the R61 (N=46) and R33 (N=72) trials will be youth ages 10 to 17 with a primary anxiety disorder (Separation, Social, Generalized). In the R61 trial, youth will be randomly assigned to receive 16 sessions over 4 weeks of either a personalized cognitive bias modification program for interpretation bias (CBM-I) or a computerized control condition (ICC). If CBM-I reduces interpretation bias significantly more than the ICC, the R33 trial will commence. In the R33, youth will be randomly assigned to either CBM-I or an equal amount of time in a cognitive restructuring intervention, which also aims to reduce threat-based thinking in anxiety. Please note that only the R61 phase of the trial has been completed and currently this record summary only reflects the R61 phase.
Primary Outcome
The WSAP-Y is a computerized assessment of interpretation bias in which youth indicate whether word-sentence pairings are related. This measure provides information about the degree to which youth evidence interpretation bias, as well as a behavioral (reaction time) index for bias endorsement. For the primary outcome of percent threat interpretations endorsed, the possible range is 0 (zero) to 100%. Higher percentage indicates more threat interpretation bias (i.e., the youth endorsed a higher pr
Conditions Studied
Interventions
- OTHER Cognitive Bias Modification for Interpretations (CBM-I)
- OTHER Interpretation Control Condition (ICC)
Study Locations (1)
Colorado
- BRAVE Lab, Department of Psychology, University of Denver - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-06-20 |
| Est. Completion | 2023-11-15 |
| Phase | NA |
What the finished NCT04245501 record still lists
NCT04245501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Anxiety Disorders appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Bias Modification for Interpretations (CBM-I) is the first listed.
NCT04245501 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04245501 about?
NCT04245501 is a clinical study titled "Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety". Anxiety is the most common mental health problem in children and adolescents. This two-phased study will test the effects of an experimental computerized intervention aimed at reducing threat-based thinking (i.e., interpretation bias) in anxious youth. Participants in both the R61 (N=46) and R33 (N=...
What is the current status of trial NCT04245501?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2020-06-20. Estimated completion is 2023-11-15.
What conditions does trial NCT04245501 study?
This clinical trial studies the following conditions: Anxiety Disorders.
What interventions are being tested in trial NCT04245501?
The interventions under investigation include: Cognitive Bias Modification for Interpretations (CBM-I) (OTHER), Interpretation Control Condition (ICC) (OTHER).
Who is sponsoring clinical trial NCT04245501?
This trial is sponsored by University of Denver, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04245501 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04245501's enrollment target sits among peer trials
50 67th of 84 higher than 17 of 84 other Anxiety Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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